Title 21, Part 884 — Obstetrical and Gynecological Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Viscometer for cervical mucus.

Endocervical aspirator.

Endometrial aspirator.

Endometrial brush.

Endometrial suction curette and accessories.

Endometrial washer.

Uterotubal carbon dioxide insufflator and accessories.

Perineometer.

Amniotic fluid sampler (amniocentesis tray).

Fetal blood sampler.

Transabdominal amnioscope (fetoscope) and accessories.

Colposcope.

Culdoscope and accessories.

Transcervical endoscope (amnioscope) and accessories.

Hysteroscope and accessories.

Hysteroscopic insufflator.

Closed loop hysteroscopic insufflator with cutter-coagulator.

Gynecologic laparoscope and accessories.

Laparoscopic insufflator.

Obstetric data analyzer.

Obstetric-gynecologic ultrasonic imager.

Fetal cardiac monitor.

Fetal electroencephalographic monitor.

Fetal phonocardiographic monitor and accessories.

Fetal ultrasonic monitor and accessories.

Fetal scalp circular (spiral) electrode and applicator.

Fetal scalp clip electrode and applicator.

Intrauterine pressure monitor and accessories.

External uterine contraction monitor and accessories.

Home uterine activity monitor.

Perinatal monitoring system and accessories.

Computerized Labor Monitoring System.

Fetal stethoscope.

Obstetric ultrasonic transducer and accessories.

Telethermographic system.

Liquid crystal thermographic system.

Breast lesion documentation system.

Cervical drain.

Vaginal pessary.

Fallopian tube prosthesis.

Vaginal stent.

Gynecologic laparoscopic power morcellation containment system.

Endoscopic electrocautery and accessories.

Gynecologic electrocautery and accessories.

Bipolar endoscopic coagulator-cutter and accessories.

Unipolar endoscopic coagulator-cutter and accessories.

Expandable cervical dilator.

Hygroscopic Laminaria cervical dilator.

Vibratory cervical dilators.

Fetal vacuum extractor.

Fetal head elevator.

Obstetric forceps.

Obstetric fetal destructive instrument.

Obstetric-gynecologic general manual instrument.

Obstetric-gynecologic specialized manual instrument.

Gynecologic surgical laser.

Obstetric table and accessories.

Specialized surgical instrumentation for use with urogynecologic surgical mesh.

Metreurynter-balloon abortion system.

Vacuum abortion system.

Obstetric anesthesia set.

Nonpowered breast pump.

Powered breast pump.

Hemorrhoid prevention pressure wedge.

Pressure wedge for the reduction of cesarean delivery.

Abdominal decompression chamber.

Cervical cap.

Condom.

Condom with spermicidal lubricant.

Glans sheath.

Multiple-use female condom.

Single-use internal condom.

Contraceptive diaphragm and accessories.

Contraceptive intrauterine device (IUD) and introducer.

Software application for contraception.

Contraceptive tubal occlusion device (TOD) and introducer.

Perineal heater.

Menstrual cup.

Scented or scented deodorized menstrual pad.

Unscented menstrual pad.

Scented or scented deodorized menstrual tampon.

Unscented menstrual tampon.

Therapeutic vaginal douche apparatus.

Vaginal insufflator.

Powered vaginal muscle stimulator for therapeutic use.

Genital vibrator for therapeutic use.

Clitoral engorgement device.

Surgical mesh for transvaginal pelvic organ prolapse repair.

Assisted reproduction needles.

Assisted reproduction catheters.

Assisted reproduction accessories.

Assisted reproduction microtools.

Assisted reproduction micropipette fabrication instruments.

Assisted reproduction micromanipulators and microinjectors.

Assisted reproduction labware.

Intravaginal culture system.

Assisted reproduction water and water purification systems.

Reproductive media and supplements.

Assisted reproductive microscopes and microscope accessories.

Assisted Reproduction Embryo Image Assessment System.

Assisted reproduction laser system.